Commission Implementing Regulation (EU) 2023/2701 of 4 December 2023 granting a Union authorisation for the single biocidal product EuLA hydra-lime 23 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Date: 2023-12-04
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal welfare, biocide, chemical product, decontamination, market approval, pharmaceutical product








L_202302701EN.000101.fmx.xml












Official Journal of the European Union


EN
Series L













2023/2701


5.12.2023







            COMMISSION IMPLEMENTING REGULATION (EU) 2023/2701
of 4 December 2023
         
granting a Union authorisation for the single biocidal product ‘EuLA hydra-lime 23’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 44(5), first subparagraph, thereof,

Whereas:







(1)


On 29 March 2018, European Lime Association aisbl submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for a Union authorisation of a single biocidal product named ‘EuLA hydra-lime 23’ of product-types 2 and 3, as described in Annex V to that Regulation, providing written confirmation that the competent authority of France had agreed to evaluate the application. The application was recorded under case number BC-JR038510-32 in the Register for Biocidal Products.












(2)


‘EuLA hydra-lime 23’ contains calcium dihydroxide (hydrated lime) as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2 and 3.












(3)


On 13 December 2021, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency.












(4)


On 5 July 2022, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘EuLA hydra-lime 23’ and the final assessment report on the single biocidal product, in accordance with Article 44(3) of Regulation (EU) No 528/2012.












(5)


The opinion concludes that ‘EuLA hydra-lime 23’ is a biocidal product within the meaning of Article 3(1), point (a), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) of that Regulation.












(6)


On 18 July 2022, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.












(7)


The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘EuLA hydra-lime 23’.












(8)


The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,





HAS ADOPTED THIS REGULATION:



Article 1
A Union authorisation with authorisation number EU-0028954-0000 is hereby granted to European Lime Association aisbl for the making available on the market and use of the single biocidal product ‘EuLA hydra-lime 23’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 25 December 2023 to 30 November 2033.


Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 December 2023.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 167, 27.6.2012, p. 1.

(2)  ECHA opinion of 14 June 2022 on the Union authorisation of ‘EULA HYDRA-LIME 23’ (ECHA/BPC/341/2022) (https://echa.europa.eu/it/opinions-on-union-authorisation).




ANNEX
Summary of product characteristics for a biocidal product

EuLA hydra-lime 23


Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)


Product type 3 – Veterinary hygiene (Disinfectants)


Authorisation number: EU-0028954-0000


R4BP asset number: EU-0028954-0000

1.   ADMINISTRATIVE INFORMATION
1.1.   Trade name(s) of the product







Trade name(s)


EuLA hydra-lime 23




1.2.   Authorisation holder








Name and address of the authorisation holder


Name


European Lime Association aisbl




Address


c/o IMA-Europe aisbl, Rue des Deux Églises 26, box 2, 1000 Brussels, Belgium




Authorisation number


EU-0028954-0000





R4BP asset number



EU-0028954-0000




Date of the authorisation


25 December 2023




Expiry date of the authorisation


30 November 2033




1.3.   Manufacturer(s) of the product







Name of manufacturer


Cal Industrial SL




Address of manufacturer


Pedro I, 19-21, 31007 Pamplona, Spain




Location of manufacturing sites


Pedro I, 19-21, 31 007 Pamplona, Spain













Name of manufacturer


Calera de Alzo, S. L.




Address of manufacturer


Postal number: 20.268, Egileor auzoa, 101, Altzo (Guipúzcoa), Spain




Location of manufacturing sites


Egileor auzoa, 101, Altzo (Guipúzcoa), Spain













Name of manufacturer


Caleras de San Cucao, S.A.




Address of manufacturer


Agüera s/n, 33425 San Cucao de Llanera, Spain




Location of manufacturing sites


Agüera s/n, 33425 San Cucao de Llanera, Spain













Name of manufacturer


Cales Pascual S.L.




Address of manufacturer


C/Cura Bau, 15, 46112 Valencia, Spain




Location of manufacturing sites


Ctra. Valencia-Ademuz, KM 9.3. Paterna, Valencia, Spain













Name of manufacturer


CalGov




Address of manufacturer


Carretera Fuente, Apartado 2, 41560 Estepa, Spain




Location of manufacturing sites


Carretera Fuente, Apartado 2, 41560 Estepa, Spain













Name of manufacturer


Carmeuse Chaux




Address of manufacturer


215 route d’Arras, 62320 Bois Bernard, France




Location of manufacturing sites


215 route d’Arras, 62320 Bois Bernard, France













Name of manufacturer


Carmeuse Czech Republic s.r.o.




Address of manufacturer


Mokrá 359, 664 04 Mokrá, Czechia




Location of manufacturing sites


závod Vápenka Mokrá, Mokrá 359, 664 04 Mokrá , Czechia













Name of manufacturer


Carmeuse Holding Srl




Address of manufacturer


Str. Carierei nr. 127A, 500047 Brașov, Romania




Location of manufacturing sites


Str. Principală 1, 337457 Com. Șoimuș, Romania. Valea Mare Pravăț, 117805 Câmpulung, Romania













Name of manufacturer


Carmeuse Hungaria kft




Address of manufacturer


HRSZ 064/1, 7827 Beremend, Hungary




Location of manufacturing sites


HRSZ 064/1, 7827 Beremend, Hungary













Name of manufacturer


Carmeuse Nederland BV




Address of manufacturer


Nijverheidsstraat 32, 2802 AL Gouda, Netherlands




Location of manufacturing sites


Nijverheidsstraat 32, 2802 AL Gouda, Netherlands













Name of manufacturer


Carmeuse SA




Address of manufacturer


Rue du Château 13a, 5300 Seilles, Belgium




Location of manufacturing sites







Rue du Val Notre Dame 300, 4520 Moha, Belgium




Rue du Château 13a, 5300 Seilles, Belgium

















Name of manufacturer


Carmeuse Slovakia s.r.o.




Address of manufacturer


Slavec, 049 11 Slavec, Slovakia




Location of manufacturing sites


závod Vápenka Slavec, Slavec 179, 049 11 Slavec, Slovakia













Name of manufacturer


Carrières et Chaux Balthazard et Cotte




Address of manufacturer


Rue du Pra Paris, 38360 Sassenage, France




Location of manufacturing sites


Rue du Pra Paris, 38360 Sassenage, France













Name of manufacturer


Carrières et fours à chaux de Dugny




Address of manufacturer


BP 1, 55100 Dugny-sur-Meuse, France




Location of manufacturing sites


BP 1, 55100 Dugny-sur-Meuse, France













Name of manufacturer


Cementos Tudela Veguín, S.A.U.




Address of manufacturer


CL Argüelles 25, 33003 Oviedo, Asturias, Spain




Location of manufacturing sites


CL Tino Casal, s/n., 33910 Tudela Veguín, Asturias, Spain













Name of manufacturer


Chaux de Boran




Address of manufacturer


Route de Boran, 60640 Précy-Sur-Oise, France




Location of manufacturing sites


Route de Boran, 60640 Précy-Sur-Oise, France













Name of manufacturer


Chaux de Bretagne




Address of manufacturer


—, 53600 Evron, France




Location of manufacturing sites


—, 53600 Evron, France













Name of manufacturer


Chaux de la Tour




Address of manufacturer


1 chemin des Chaux de la Tour, 13820 Ensues La Redonne, France




Location of manufacturing sites


1 chemin des Chaux de la Tour, 13820 Ensues La Redonne, France













Name of manufacturer


Clogrennane Lime LTD




Address of manufacturer


Clogrennane, R93 EV26 Carlow, Ireland




Location of manufacturing sites


Clogrennane, R93 EV26 Carlow, Ireland













Name of manufacturer


Dumont-Wautier




Address of manufacturer


Rue la Mallieue, 95, 4470 Saint-Georges-sur-Meuse, Belgium




Location of manufacturing sites


Rue la Mallieue, 95, 4470 Saint-Georges-sur-Meuse, Belgium













Name of manufacturer


Etablissement Leon Lhoist




Address of manufacturer


Usine de On-Jemelle, 6900 Marche-en-Famenne, Belgium




Location of manufacturing sites


Usine de On-Jemelle, 6900 Marche-en-Famenne, Belgium













Name of manufacturer


Européenne des Chaux et Liants




Address of manufacturer


2745 route du Bugey, CS22015, 38307 Bourgoin-Jallieu, France




Location of manufacturing sites


Usine de Duin, 38460 Trept, France













Name of manufacturer


Lhoist Central Europe/Lhoist Česká republika a Slovensko Vápenka Čertovy schody a.s




Address of manufacturer


Tmaň 200, 267 21 Tmaň, Czechia




Location of manufacturing sites


Tmaň 200, 267 21 Tmaň, Czechia













Name of manufacturer


Lhoist Faxe Kalk A/S




Address of manufacturer


Hovedgaden 13, 4654 Faxe Ladeplads, Denmark




Location of manufacturing sites


Gl. Strandvej 14, 4640 Faxe, Denmark













Name of manufacturer


Lhoist France Ouest




Address of manufacturer


15 rue Henri Dagallier, 38100 Grenoble, France




Location of manufacturing sites


15 rue Henri Dagallier, 38100 Grenoble, France













Name of manufacturer


Lusical




Address of manufacturer


Valverde, 2025-201 Alcanede, Portugal




Location of manufacturing sites


Valverde, 2025-201 Alcanede, Portugal













Name of manufacturer


Nordkalk AB




Address of manufacturer


Box 901, SE-731 29 Köping, Sweden




Location of manufacturing sites







Nordkalk AB, Köping, Kungsängsvägen 22, SE-731 36 Köping, Sweden




Nordkalk AB, Landskrona, Verkstadsgatan, SE-261 35 Landskrona, Sweden




Nordkalk AB, Luleå, Viktoriavägen 5, SE-974 37 Luleå, Sweden

















Name of manufacturer


Nordkalk Oy Ab




Address of manufacturer


Skräbbölevägen 18, FI-21600 Pargas, Finland




Location of manufacturing sites







Nordkalk Oy Ab, Louhi, Louhi, FI-57100 Savonlinna, Finland




Nordkalk Oy Ab, Tytyri, Tytyrinkatu 7, FI-08100 Lohja, Finland

















Name of manufacturer


Singleton Birch




Address of manufacturer


Melton Ross Quarries, Barnetby, DN38 6AE N. Lincolnshire. United Kingdom




Location of manufacturing sites


Melton Ross Quarries, Barnetby, DN38 6AE N. Lincolnshire. United Kingdom













Name of manufacturer


SMA Mineral AB




Address of manufacturer


—, SE-682 27 Filipstad, Sweden




Location of manufacturing sites







Luleå Lime Plant, C/O SSAB Europe, SE-971 88 Luleå, Sweden




Boda Lime Plant, Kärvsåsen Kalkverksvägen 15, SE-795 96 Boda kyrkby, Sweden




Rättivik lime plant, Kalkvagen 7, SE-795 32 Rättvik, Sweden




SSAB Industriområde, Kalkverket, SE-613 80 Oxelösund, Sweden




Mo Industripark, Verkstedsøypa, NO-8626 Mo i Rana, Norway

















Name of manufacturer


SMA Mineral Burgas Var LTD




Address of manufacturer


dis. Pobeda, Chataldzha str. No 52, 8002 Burgas, Bulgaria




Location of manufacturing sites


dis. Pobeda, Chataldzha str. No 52, 8002 Burgas, Bulgaria













Name of manufacturer


SMA Mineral Oy




Address of manufacturer


—, FI-95450 Tornio, Finland




Location of manufacturing sites


SMA Mineral Oy, Röyttä Lime Plant, Selleenkatu 281, FI-95450 Tornio, Finland













Name of manufacturer


Tarmac, Lime and Powders




Address of manufacturer


Tunstead House, Wormhill, Buxton, SK17 8TG Derbyshire, United Kingdom




Location of manufacturing sites


Tunstead House, Wormhill, Buxton, SK17 8TG Derbyshire, United Kingdom













Name of manufacturer


Unicalce S.p.A




Address of manufacturer


Via Tonio da Belledo, 30, 23900 Lecco LC, Italy




Location of manufacturing sites







Via Ponti, 18, 24012 Val Brembilla BG, Italy




Via Lisso, 12, 24010 Sedrina BG, Italy




Strada Amerina Località S.Pellegrino, 05035 Narni TR, Italy




Via Di S.Vincenzo 21, 57021 Campiglia Marittima LI, Italy




S.S.Appia km 134, 04020 Itri LT, Italy




Contrada Lupini – C.P.33, 74019 Palagiano TA, Italy

















Name of manufacturer


Wietersdorfer & Peggauer Zementwerke GmbH




Address of manufacturer


Wietersdorf 1, 9373 Klein St. Paul, Austria




Location of manufacturing sites


Alois-Kern-Straße 1, 8120 Peggau, Austria













Name of manufacturer


Zakłady Wapiennicze Lhoist S.A.




Address of manufacturer


ul. Wapiennicza 7, 46-050 Tarnów Opolski, Poland




Location of manufacturing sites







ul. Fabryczna 22, 47-316 Górażdże, Poland




ul. Bolesława Chrobrego 77B, 59-550 Wojcieszów, Poland

















Name of manufacturer


Zement- und Kalkwerke Otterbein GmbH & Co. KG




Address of manufacturer


Hauptstrasse 50, 36137 Grossenlueder-Mues, Germany




Location of manufacturing sites


Georg-Otterbein-Strasse 123, 36137 Grossenlueder-Mues, Germany













Name of manufacturer


SMA Mineral AS




Address of manufacturer


Postbox 500, NO-8601 Mo i Rana, Norway




Location of manufacturing sites


Mo Industripark, Verkstedsøypa, NO-8626 Mo i Rana, Norway




1.4.   Manufacturer(s) of the active substance(s)







Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


Cal Industrial SL




Address of manufacturer


Pedro I, 19-21, 31007 Pamplona, Spain




Location of manufacturing sites


Pedro I, 19-21, 31007 Pamplona, Spain













Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


Calera de Alzo, S. L.




Address of manufacturer


20.268, Egileor auzoa, 101 Altzo (Guipúzcoa), Spain




Location of manufacturing sites


Egileor auzoa, 101 Altzo (Guipúzcoa), Spain













Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


Caleras de San Cucao, S.A.




Address of manufacturer


Agüera s/n, 33425 San Cucao de Llanera, Spain




Location of manufacturing sites


Agüera s/n, 33425 San Cucao de Llanera, Spain













Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


Cales Pascual S.L.




Address of manufacturer


C/Cura Bau, 15, 46112 Valencia, Spain




Location of manufacturing sites


Ctra. Valencia-Ademuz, KM 9.3., Paterna, Spain













Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


CalGov




Address of manufacturer


Carretera Fuente, Apartado 2, 41560 Estepa, Spain




Location of manufacturing sites


Carretera Fuente, Apartado 2, 41560 Estepa, Spain













Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


Carmeuse Chaux




Address of manufacturer


215 route d’Arras, 62320 Bois Bernard, France




Location of manufacturing sites


215 route d’Arras, 62320 Bois Bernard, France













Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


Carmeuse Czech Republic s.r.o.




Address of manufacturer


Mokrá 359, 664 04 Mokrá, Czechia




Location of manufacturing sites


závod Vápenka Mokrá, Mokrá 359, 664 04 Mokrá, Czechia













Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


Carmeuse Holding Srl




Address of manufacturer


Str. Carierei nr. 127A, 500047 Brașov, Romania




Location of manufacturing sites







Str. Principală 1, 337457 Com. Șoimuș, Romania.




Valea Mare Pravăț, 117805 Câmpulung, Romania

















Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


Carmeuse Hungaria kft




Address of manufacturer


HRSZ 064/1, 7827 Beremend, Hungary




Location of manufacturing sites


HRSZ 064/1, 7827 Beremend, Hungary













Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


Carmeuse Nederland BV




Address of manufacturer


Nijverheidsstraat 32, 2802 AL Gouda, Netherlands




Location of manufacturing sites


Nijverheidsstraat 32, 2802 AL Gouda, Netherlands













Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


Carmeuse SA




Address of manufacturer


Rue du Château 13a, 5300 Seilles, Belgium




Location of manufacturing sites







Rue du Val Notre Dame 300, 4520 Moha, Belgium




Rue du Château 13a, 5300 Seilles, Belgium

















Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


Carmeuse Slovakia s.r.o




Address of manufacturer


Slavec, 049 11 Slavec, Slovakia




Location of manufacturing sites


závod Vápenka Slavec 179, 04911 Slavec, Slovakia













Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


Carrières et Chaux Balthazard et Cotte




Address of manufacturer


Rue du Pra Paris, 38360 Sassenage, France




Location of manufacturing sites


Rue du Pra Paris, 38360 Sassenage, France













Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


Carrières et fours à chaux de Dugny




Address of manufacturer


BP 1, 55100 Dugny-sur-Meuse, France




Location of manufacturing sites


BP 1, 55100 Dugny-sur-Meuse, France













Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


Cementos Tudela Veguín, S.A.U.




Address of manufacturer


CL Argüelles 25, 33003 Oviedo, Asturias, Spain




Location of manufacturing sites


CL Tino Casal, s/n., 33910 Tudela Veguín, Asturias, Spain













Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


Chaux de Boran




Address of manufacturer


Route de Boran, 60640 Précy-Sur-Oise, France




Location of manufacturing sites


Route de Boran, 60640 Précy-Sur-Oise, France













Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


Chaux de Bretagne




Address of manufacturer


—, 53600 Evron, France




Location of manufacturing sites


—, 53600 Evron, France













Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


Chaux de la Tour




Address of manufacturer


1 chemin des Chaux de la Tour, 13820 Ensues La Redonne, France




Location of manufacturing sites


1 chemin des Chaux de la Tour, 13820 Ensues La Redonne, France













Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


Clogrennane Lime LTD




Address of manufacturer


Clogrennane, R93 EV26 Carlow, Ireland




Location of manufacturing sites


Clogrennane, R93 EV26 Carlow, Ireland













Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


Dumont-Wautier




Address of manufacturer


Rue la Mallieue, 95, 4470 Saint-Georges-sur-Meuse, Belgium




Location of manufacturing sites


Rue la Mallieue, 95, 4470 Saint-Georges-sur-Meuse, Belgium













Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


Etablissement Leon Lhoist




Address of manufacturer


Usine de On-Jemelle, 6900 Marche-en-Famenne, Belgium




Location of manufacturing sites


Usine de On-Jemelle, 6900 Marche-en-Famenne, Belgium













Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


Européenne des Chaux et Liants




Address of manufacturer


2745 route du Bugey, CS22015, 38307 Bourgoin-Jallieu, France




Location of manufacturing sites


Usine de Duin, 38460 Trept, France













Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


Lhoist France Ouest




Address of manufacturer


15 rue Henri Dagallier, 38100 Grenoble, France




Location of manufacturing sites


15 rue Henri Dagallier, 38100 Grenoble, France













Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


Lusical




Address of manufacturer


Valverde, 2025-201 Alcanede, Portugal




Location of manufacturing sites


Valverde, 2025-201 Alcanede, Portugal













Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


Nordkalk AB




Address of manufacturer


Box 901, SE-731 29 Köping, Sweden




Location of manufacturing sites







Nordkalk AB, Köping, Kungsängsvägen 22, SE-731 36 Köping, Sweden




Nordkalk AB, Landskrona, Verkstadsgatan, SE-261 35 Landskrona, Sweden




Nordkalk AB, Luleå, Viktoriavägen 5, SE-974 37 Luleå, Sweden

















Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


Nordkalk Oy Ab




Address of manufacturer


Skräbbölevägen 18, FI-21600 Pargas, Finland




Location of manufacturing sites







Nordkalk Oy Ab, Louhi, Louhi, FI-57100 Savonlinna, Finland




Nordkalk Oy Ab, Tytyri, Tytyrinkatu 7, FI-08100 Lohja, Finland

















Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


Singleton Birch




Address of manufacturer


Melton Ross Quarries, Barnetby, DN38 6AE N. Lincolnshire, United Kingdom




Location of manufacturing sites


Melton Ross Quarries, Barnetby, DN38 6AE N. Lincolnshire, United Kingdom













Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


SMA Mineral AB




Address of manufacturer


—, SE-682 27 Filipstad, Sweden




Location of manufacturing sites







Luleå Lime Plant, C/O SSAB Europe, SE-971 88 Luleå, Sweden




Boda Lime Plant, Kärvsåsen Kalkverksvägen 15, SE-795 96 Boda kyrkby, Sweden




Rättivik lime plant, Kalkvagen 7, SE-795 32 Rättvik, Sweden




SSAB Industriområde, Kalkverket, SE-613 80 Oxelösund, Sweden




Mo Industripark, Verkstedsøypa, NO-8626 Mo i Rana, Norway

















Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


SMA Mineral Burgas Var LTD




Address of manufacturer


Chataldzha str. No 52, 8002 Burgas, dis. Pobeda Bulgaria




Location of manufacturing sites


Chataldzha str. No 52, 8002 Burgas, dis. Pobeda Bulgaria













Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


SMA Mineral Oy




Address of manufacturer


—, FI-95450 Tornio, Finland




Location of manufacturing sites


SMA Mineral Oy, Röyttä Lime Plant, Selleenkatu 281, FI-95450 Tornio, Finland













Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


Unicalce S.p.A




Address of manufacturer


Via Tonio da Belledo, 30, 23900 Lecco LC, Italy




Location of manufacturing sites







Via Ponti, 18, 24012 Val Brembilla BG, Italy




Via Lisso, 12, 24010 Sedrina BG, Italy




Strada Amerina Località S.Pellegrino, 05035 Narni TR, Italy




Via Di S.Vincenzo 21, 57021 Campiglia Marittima LI, Italy




S.S.Appia km 134, 04020 Itri LT, Italy




Contrada Lupini – C.P.33, 74019 Palagiano TA, Italy

















Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


Wietersdorfer & Peggauer Zementwerke GmbH




Address of manufacturer


Wietersdorf 1, 9373 Klein St. Paul, Austria




Location of manufacturing sites


Alois-Kern-Straße 1, 8120 Peggau, Austria













Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


Zakłady Wapiennicze Lhoist S.A.




Address of manufacturer


ul. Wapiennicza 7, 46-050 Tarnów Opolski, Poland




Location of manufacturing sites







ul. Fabryczna 22, 47-316 Górażdże, Poland




ul. Bolesława Chrobrego 77B, 59-550 Wojcieszów, Poland

















Active substance


Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime




Name of manufacturer


Zement- und Kalkwerke Otterbein GmbH & Co. KG




Address of manufacturer


Hauptstrasse 50, 36137 Grossenlueder-Mues, Germany




Location of manufacturing sites


Georg-Otterbein-Strasse 123, 36137 Grossenlueder-Mues, Germany




2.   PRODUCT COMPOSITION AND FORMULATION
2.1.   Qualitative and quantitative information on the composition of the product











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime


 


Active Substance


1305-62-0


215-137-3


100,0 




2.2.   Type of formulation

DP – Dustable powder WP – Wettable powder (only for use for disinfection of animal accommodations; limewashing of walls)
3.   HAZARD AND PRECAUTIONARY STATEMENTS






Hazard statements


Causes skin irritation.
Causes serious eye damage.
May cause respiratory irritation.




Precautionary statements


Avoid breathing dust.
Wash hands thoroughly after handling.
Use only outdoors or in a well-ventilated area.
Wear protective gloves, protective clothing, eye protection and face protection.
IF ON SKIN: Wash with plenty of water.
Specific treatment (see instructions on this label).
If skin irritation occurs: Get medical advice.
Take off contaminated clothing and wash it before reuse.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
Immediately call a POISON CENTRE/doctor/physician.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
Call a POISON CENTRE/doctor if you feel unwell.
Store in a well-ventilated place. Keep container tightly closed.
Store locked up.
Dispose of container in accordance with local regulations.




4.   AUTHORISED USE(S)
4.1.   Use description


Table 1


Use # 1 – Disinfection of sewage sludge







Product type


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


—




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: —
Scientific name: Endoparasites
Common name: Helminth eggs
Development stage: —




Field(s) of use


Indoor




Application method(s)


Method: Automatic direct application
Detailed description:
The product is dosed into the sewage sludge and mixed by means of a blender. The dry product is mixed with the sewage sludge in an open mixer.
The product shall be loaded by fully automated processes.




Application rate(s) and frequency


Application Rate: 0,2–2 kg product/kg dry weight of substrate; typical dry solids content – 12–25 % in sewage sludge. The application rate must be sufficient to maintain a pH > 12 during the contact time.
Dilution (%): – Ready-to-use (RTU) product
Number and timing of application:
Contact time: 24 hours to 90 days for endoparasites (helminth eggs) – the specific contact time depends on several parameters (e.g. temperature, content of dry matter, etc.). Preliminary laboratory tests must be performed to guarantee efficacy.




Category(ies) of users


Professional




Pack sizes and packaging material


Bulk powder
Big bags or sacks (with Polypropylene (PP) or polyethylene (PE) inner layer): 500–1 000  kg




4.1.1.   Use-specific instructions for use







—


The dose must be sufficient to maintain a pH > 12 during the contact time.










—


Application rate: 0,2–2 kg product/kg dry weight of substrate; typical dry solids content – 12–25 % in sewage sludge.




The ratios may vary between applications and treatment plant designs. The user should ensure that the treatment is effective through preliminary laboratory tests that guarantee efficacy according to the legislation applicable to each case.
4.1.2.   Use-specific risk mitigation measures







—


The loading of the product into the treatment unit and the application must be done fully automatically. The loading into the treatment unit and the disposal of empty bags and sacs must be performed using a telehandler (including a closed cabin).










—


During the loading of the product and the disposal of empty bags, wear:






—


respiratory protective equipment (RPE) of at least assigned protection factor (APF) 40 (airtight face piece covering eyes, nose, mouth and chin according to European Standard (EN) 149 with a P3 filter or equivalent);










—


chemical resistant gloves classified under EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information);










—


protective coverall in accordance with EN 13982 or equivalent (coverall material to be specified by the authorisation holder within the product information).














—


During the treatment of sewage sludge, the wearing of air-fed or canister RPE specific for ammonia gas in accordance with EN 14387 or equivalent, is recommended in the absence of collective management measures to estimate and prevent an exposure greater than the EU occupational exposure limit value (OEL) of 14 mg/m3 for that gas.










—


During the manual handling of treated sewage sludge wear protective gloves in accordance with EN 374 or equivalent and protective coverall in accordance with EN 14126 or equivalent protecting against the intrinsic properties of the sewage sludge.










—


The provisions on personal protective equipment are without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work.










—


See Section 6 for the full titles of the EN standards and legislation.










—


The cleaning of the unit treatment must be avoided or performed with an automated process with no exposure of the professional.




4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

—
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

—
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

—
4.2.   Use description


Table 2


Use # 2 – Disinfection of manure







Product type


PT03 – Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


—




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Viruses
Common name: Viruses
Development stage:
Scientific name: Endoparasites
Common name: Helminth eggs
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Automatic direct application
Detailed description:
The product is mixed with the manure. The product is dosed into the manure and mixed by means of a blender. The product should be loaded by fully automated processes.




Application rate(s) and frequency


Application Rate: —
Dilution (%): – RTU product
Number and timing of application:
The application rate must be sufficient to maintain a pH > 12 during the contact time.
Contact time: 72 hours to 90 days for endoparasites (helminth eggs) – the specific contact time depends on several parameters (e.g. temperature, content of dry matter, etc.). Preliminary laboratory tests must be performed to guarantee efficacy.




Category(ies) of users


Professional




Pack sizes and packaging material


Bulk powder
Big bags or sacks (with PP or PE inner layer): 500–1 000  kg




4.2.1.   Use-specific instructions for use







—


The dose must be sufficient to maintain a pH > 12 during the contact time.










—


Do not apply more than 100 kg product/m3 of manure.










—


After the necessary contact time, remove the treated manure from the animal house. Use of the treated manure according to local legislation.




4.2.2.   Use-specific risk mitigation measures







—


The loading of the product into the treatment unit and the application must be done fully automatically.










—


The loading into the treatment unit and the disposal of empty bags and sacs must be performed using a telehandler (including a closed cabin).










—


During the loading of the product and the disposal of empty bags, wear:






—


chemical resistant gloves in accordance with EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information);










—


a protective coverall in accordance with EN 13982 or equivalent (coverall material to be specified by the authorisation holder within the product information);










—


RPE of at least APF 40 (airtight face piece covering eyes, nose, mouth and chin according to EN 149 with a P3 filter or equivalent).














—


During the treatment of manure, the wearing of air-fed or canister RPE specific for ammonia gas in accordance with EN 14387 or equivalent, is recommended in the absence of collective management measures to estimate and prevent an exposure greater than the EU occupational exposure limit value (OEL) of 14 mg/m3 for that gas.










—


During the manual handling of treated manure wear protective gloves in accordance with EN 374 or equivalent and protection coverall in accordance with EN 14126 or equivalent protecting against the intrinsic properties of the manure.










—


The provisions on personal protective equipment are without prejudice to the application of Directive 98/24/EC and other Union legislation in the area of health and safety at work.










—


See Section 6 for the full titles of the EN standards and legislation.










—


The cleaning of the unit treatment must be avoided or performed with an automated process with no exposure of the professional.










—


Do not apply the product if releases from animal housings or manure/slurry storage areas can be directed to a sewage treatment plant or directly to surface water.




4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

—
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

—
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

—
4.3.   Use description


Table 3


Use # 3 – Disinfection of indoor floor surfaces of animal accomodations and transportation







Product type


PT03 – Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


—




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: —
Scientific name: Yeasts
Common name: Yeasts
Development stage: —
Scientific name: Fungi
Common name: Fungi
Development stage: —
Scientific name: viruses
Common name: Viruses
Development stage: —




Field(s) of use


Indoor




Application method(s)


Method: Direct application
Detailed description:
The product is spread directly onto the floors of animal accommodations using manual or automated techniques. Manual spreading using a shovel or semi-automated using a low-impact spreader.




Application rate(s) and frequency


Application Rate: 800 g product/m2

Dilution (%): – RTU product
Number and timing of application:
Frequency in animal housing: before each production cycle.
Frequency in animal transportation: after each animal transport.
Contact time: 48 hours




Category(ies) of users


Professional




Pack sizes and packaging material


Bulk powder
Big bags or sacks (with PP or PE inner layer): 500–1 000  kg
Paper sacks (with PP or PE inner layer): 25 kg




4.3.1.   Use-specific instructions for use

The product is spread directly onto the floors of animal accommodations and transportation, using manual or automated techniques. Manual spreading using a shovel or semi-automated using a low-impact spreader.






A.


On concrete floors:






1.


Wash the surface with running water;










2.


Sprinkle 800 g of product per m2 to cover the damp ground and add 0,9 litre/m2 of water;










3.


Leave to act for at least 48 hours;










4.


After treatment, remove the lime by brushing.














B.


On beaten-earth floors:






1.


Brush and wet the surface;










2.


Sprinkle 800 g of product per m2 on the damp ground and add 0,9 litre/m2 of water;










3.


Leave to act for at least 48 hours.










4.


After treatment, remove the lime by brushing.








4.3.2.   Use-specific risk mitigation measures







—


During the loading, the application of the product and the disposal of empty bags and sacs, wear:






—


RPE of at least APF 40 (airtight face piece covering eyes, nose, mouth and chin according to EN 149 with a P3 filter or equivalent);










—


chemical resistant gloves in accordance with EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information);










—


protective coverall in accordance with EN 13982 or equivalent (coverall material to be specified by the authorisation holder within the product information).














—


For the use of big bags (500-1 000 kg), the loading of the product and the disposal of empty bags must be performed fully automatically using a telehandler (including a closed cabin).










—


During the loading of small bags (25 kg), thoroughly empty out the bag in order to minimise the remaining powder.










—


For the disposal of small empty bags, moisten the bag and fold it carefully in order to avoid any spills.










—


During the disposal of the product after the application, wear:






—


RPE of at least APF 40 (airtight face piece covering eyes, nose, mouth and chin according to EN 149 with a P3 filter or equivalent);










—


chemical resistant gloves in accordance with EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information);










—


protective coverall in accordance with EN 13982 or equivalent (coverall material to be specified by the authorisation holder within the product information).














—


The provisions on personal protective equipment are without prejudice to the application of Directive 98/24/EC and other Union legislation in the area of health and safety at work.










—


See Section 6 for the full titles of the EN standards and legislation.










—


Animals shall not be present during all the treatment duration.










—


Remove residues of the product on the ground by thorough sweeping before re-entry of animals.










—


Feed and drinking water must be carefully covered or removed during the application of the product.










—


Do not apply the product if releases from animal housings, manure/slurry storage areas, or animal transportation disinfection areas can be directed to a sewage treatment plant or directly to surface water.




4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

—
4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

After treatment, remove the lime by brushing. Collect the resulting dry waste and recycle them as agricultural liming material or dispose the dry waste according to local requirements.
For animal transportation use only: after brushing and the required contact time, rinse and clean the vehicle.
4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

—
4.4.   Use description


Table 4


Use # 4 – Disinfection of animal accommodations; limewashing of walls







Product type


PT03 – Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


—




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: —
Scientific name: Yeasts
Common name: Yeasts
Development stage: —
Scientific name: Fungi
Common name: Fungi
Development stage: —
Scientific name: Viruses
Common name: Viruses
Development stage: —




Field(s) of use


Indoor




Application method(s)


Method: Direct application with a brush
Detailed description:
—




Application rate(s) and frequency


Application Rate: 800 g product/m2

Dilution (%): —
Number and timing of application:
The product is suspended in water (50 % w/v) prior to its application by brushing on the walls.
Contact time: 48 hours
Frequency: before each production cycle




Category(ies) of users


Professional




Pack sizes and packaging material


Bulk powder
Big bags or sacks (with PP or PE inner layer): 500–1 000  kg




4.4.1.   Use-specific instructions for use

For one layer:
Application method for 150 to 200 m2 of wall (depending on the porosity of the wall):






1.


Clean the surface with running water before the application of the product.










2.


Introduce 25 kg of product into 50 litres of water;










3.


Let the mixture rest for 12 hours;










4.


Mix the resulting mixture and brush onto the wall;










5.


Leave to act for at least 48 hours.




The application rate is 125–167 g product/m2 for a single layer. A final application rate of 800 g product/m2 is required, therefore 5–7 coats should be applied, depending on the porosity of the wall.
Stir before and during application.
The product must be first fully automatically transferred to a medium lower volume tank. Then, the product is manually loaded from the medium tank to a bucket.
4.4.2.   Use-specific risk mitigation measures







—


During the loading of the product and the disposal of empty bags and sacs, wear:






—


chemical resistant gloves in accordance with EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information);










—


protective coverall in accordance with EN 13982 (coverall material to be specified by the authorisation holder within the product information);










—


RPE of at least APF 40 (airtight face piece covering eyes, nose, mouth and chin according to EN 149 with a P3 filter or equivalent).














—


During the application of the product on the walls, wear:






—


chemical resistant gloves in accordance with EN 374 (glove material to be specified by the authorisation holder within the product information);










—


protective coverall in accordance with EN 13034 (coverall material to be specified by the authorisation holder within the product information);










—


RPE of at least APF 40 (airtight face piece covering eyes, nose, mouth and chin according to EN 149 with a P1 filter or equivalent).














—


The provisions on personal protective equipment are without prejudice to the application of Directive 98/24/EC and other Union legislation in the area of health and safety at work.










—


See section 6 for the full titles of the EN standards and legislation.










—


The loading of the product and the disposal of empty bags and sacs must be performed fully automatically using a telehandler (including a closed cabin).










—


Minimise splashes and spills during application.










—


Do not let bystanders (including co-workers and children) touch treated surfaces until completely dry.










—


Do not apply the product if releases from animal housings or manure/slurry storage areas can be directed to a sewage treatment plant or directly to surface water.










—


Animals shall not be present during all the treatment duration.










—


Do not let animals re-enter the accommodations before complete drying of surfaces.










—


Feed and drinking water must be carefully covered or removed during the application of the product.




4.4.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

—
4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

—
4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

—
4.5.   Use description


Table 5


Use # 5 – Disinfection of floors of outdoor animal enclosures







Product type


PT03 – Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


—




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: —
Scientific name: Yeasts
Common name: Yeasts
Development stage: —
Scientific name: Fungi
Common name: Fungi
Development stage: —
Scientific name: Viruses
Common name: Viruses
Development stage: —




Field(s) of use


Outdoor




Application method(s)


Method: Direct application
Detailed description:
The product is spread directly onto the surfaces (floors) of animal enclosures using manual or automated techniques. Manual spreading using a shovel or semi-automated using a low-impact spreader.




Application rate(s) and frequency


Application Rate: 800 g product/m2

Dilution (%): – RTU product
Number and timing of application:
Contact time 48 hours
Frequency: maximum two applications per year.




Category(ies) of users


Professional




Pack sizes and packaging material


Bulk powder
Big bags or sacks (with PP or PE inner layer): 500–1 000  kg
Paper sacks (with PP or PE inner layer): 25 kg




4.5.1.   Use-specific instructions for use







—


Brush and wet the floor before the application of the product.










—


At the beginning of a production cycle, spread 800 g product/m2 of the product onto the ground and then add 0,9 litre/m2 of water.










—


Leave to act for at least 48 hours before bringing animals in the treated area.










—


For outdoor uses of the product, do not apply in the case of wind or rain.




4.5.2.   Use-specific risk mitigation measures







—


During the loading, the application of the product and the disposal of empty bags and sacs, wear:






—


RPE of at least APF 40 (airtight face piece covering eyes, nose, mouth and chin according to NF EN 149 with a P3 filter or equivalent);










—


chemical resistant gloves in accordance with EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information);










—


protective coverall in accordance with EN 13982 (coverall material to be specified by the authorisation holder within the product information).














—


For the use of big bags (500–1 000 kg), the loading of the product and the disposal of empty bags must be performed fully automatically using a telehandler (including a closed cabin).










—


During the loading of small bags (25 kg), thoroughly empty out the bags in order to minimise the remaining powder.










—


For the disposal of small empty bags, moisten the bag and fold it carefully in order to avoid any spills.










—


During the disposal of the product after the application, wear:






—


RPE of at least APF 40 (airtight face piece covering eyes, nose, mouth and chin according to NF EN 149 with a P3 filter or equivalent);










—


chemical resistant gloves in accordance with EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information);










—


protective coverall in accordance with EN 13982 (coverall material to be specified by the authorisation holder within the product information).














—


The provisions on personal protective equipment are without prejudice to the application of Directive 98/24/EC and other Union legislation in the area of health and safety at work.










—


See Section 6 for the full titles of the EN standards and legislation.










—


Do not exceed two applications per year.










—


Animals shall not be present during all the treatment duration.










—


Remove residues of the product on the ground by thorough brushing before re-entry of animals.










—


Feed and drinking water must be carefully covered or removed during the application of the product.




4.5.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

—
4.5.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging







—


After treatment, remove the lime by brushing. Collect the resulting dry waste and recycle them as agriculture liming material or dispose the dry waste according to local requirements.




4.5.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

—
5.   GENERAL DIRECTIONS FOR USE (1)

5.1.   Instructions for use







—


Comply with the instructions for use.










—


Respect the conditions of use of the product.










—


Refer to hygiene plan in place in order to ensure that necessary efficacy level is achieved.










—


For outdoor use of the product, do not apply in the case of wind or rain.




5.2.   Risk mitigation measures







—


Do not let bystanders (including co-workers and children) and pets enter the treatment area during the entire treatment duration (including the loading, the application of the product, the disposal of empty bags and sacs, the agreed contact time and the subsequent removal of the product and its residues from the ground).










—


Use only in a well-ventilated area.




5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment







—


IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.










—


IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.










—


IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.










—


IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and ease to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to healthcare personnel /doctor: the eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemical (pH > 11), amines and acids like acetic acid, formic acid or propionic acid.




5.4.   Instructions for safe disposal of the product and its packaging







—


Do not discharge unused product on the ground, into water courses, into pipes (e.g. of sinks, toilets) or down the drains.










—


Dispose of unused product, its packaging and all other waste, in accordance with local regulations.




5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage







—


Do not store at a temperature above 30 °C.










—


Protect from humidity.










—


Shelf-life: 15 months.




6.   OTHER INFORMATION
Full titles of EN standards and legislation referred to in Sections 4.1.2–4.5.2:






 


EN 149 – Respiratory protective devices – Filtering half masks to protect against particles – Requirements, testing, marking;










 


EN 374 – EN ISO 374-1: 2018: Protective gloves against dangerous chemicals and micro-organisms. Part 1: terminology and performance requirements for chemical risks;










 


EN 13982 – Protective clothing for use against solid particulates – Part 1: Performance requirements for chemical protective clothing providing protection to the full body against airborne solid particulates;










 


EN 14387 – EN 14387:2021: Respiratory protective devices – Gas filter(s) and combined filter(s) – Requirements, testing, marking;










 


EN 14126 – BS EN 14126: 2003 – Protective clothing. Performance requirements and tests methods for protective clothing against infective agent;










 


Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).






(1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.



ELI: http://data.europa.eu/eli/reg_impl/2023/2701/oj
ISSN 1977-0677 (electronic edition)